May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

This Funding Opportunity Announcement (FOA) encourages Small
Grant (R03) applications from institutions/organizations proposing to advance
knowledge on the reasons behind the divergent trends that have been observed
in health and longevity at older ages, both across industrialized nations and
across geographical areas in the United States. This FOA is intended to
capitalize on provocative findings in the literature which have been
insufficiently understood and addressed. This FOA is also intended to
capitalize on NIA’s investment in the development of cross-nationally
comparable datasets that can be harnessed to study these research questions;
these include the Health and Retirement Study (HRS), the English Longitudinal
Study on Ageing (ELSA), the Survey of Health, Ageing and Retirement in
Europe (SHARE), and the Human Mortality Data Base. Applications proposing
secondary analysis, calibration of measures across studies, development of
innovative survey measures, and linkages to administrative sources are
encouraged. Applications are not restricted to projects using the
NIA-supported datasets above and may propose research using any relevant data.

Key Dates

Posted Date

February 21, 2013

Open Date (Earliest Submission Date)

May 16, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.
Learn more.

This Funding Opportunity Announcement (FOA) encourages Small
Grant (R03) applications from institutions/organizations proposing to advance
knowledge on the reasons behind the divergent trends that have been observed in
health and longevity at older ages, both across industrialized nations and
across geographical areas in the United States. This FOA is intended to
capitalize on provocative findings in the literature which have been
insufficiently understood and addressed. This FOA is also intended to
capitalize on NIA’s investment in the development of cross-nationally
comparable datasets that can be harnessed to study these research questions;
these include the Health and Retirement Study (HRS), the English Longitudinal
Study on Ageing (ELSA), the Survey of Health, Ageing and Retirement in Europe
(SHARE), and the Human Mortality Data Base. Applications proposing secondary
analysis, calibration of measures across studies, development of innovative
survey measures, and linkages to administrative sources are encouraged.
Applications are not restricted to projects using the NIA-supported datasets
above and may propose research using any relevant data.

The NIH R03 grant mechanism supports discrete, well-defined
projects that realistically can be completed in two years and that require
limited levels of funding. Examples of the types of projects that can be
supported with the R03 mechanism include, but are not limited to: pilot or
feasibility studies, secondary analysis of existing data, small, self-contained
research projects, calibration of measures across studies, linkages to
administrative data sources, and development of research methodology. Because
the research plan is restricted to 6 pages, an R03 grant application will not
have the same level of detail or extensive discussion found in an R01
application. Accordingly, reviewers should evaluate the conceptual framework
and general approach to the problem, placing less emphasis on methodological
details and certain indicators traditionally used in evaluating the scientific
merit of R01 applications including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or from investigator-generated data.
Preliminary data are not required, particularly in applications proposing pilot
or feasibility studies.

Background

Life expectancy at birth in the United States has improved
dramatically over the past century. Also, throughout the second half of the
century, advances in medicine—particularly in the treatment of heart disease
and stroke—along with healthier lifestyles, better access to health care, and
better overall health before age 65 combined to produce impressive improvements
in life expectancy above age 65. Yet U.S. life expectancy (at birth and at
older ages) -- especially for women – has lagged behind other wealthy nations
since 1980. And evidence from cross-national research indicates that older
Americans get sicker sooner compared to older Europeans. Within the United
States, similar disparities in health and longevity are observed across
geographical areas.

The recent availability of longitudinal data expressly
designed to be cross-nationally comparable has begun to prompt research inquiry
into the underlying dynamics of, and reasons for, these differences in health
and longevity at older ages. For example, research using the Health and
Retirement Study (HRS), English Longitudinal Study of Ageing (ELSA) and the
National Health and Nutrition Study (NHANES), indicates that older white
non-Hispanic U.S. adults aged 55-64 are less healthy than their English
counterparts for a range of diseases including diabetes, hypertension, heart
disease, myocardial infarction, stroke, lung disease, and cancer (Banks et al.,
2006). This analysis also controlled for education and a standard set of comparably-measured
behavioral risk factors (smoking, overweight, obesity, and alcohol drinking),
which explained little of these health differences. In addition, analysis of
biomeasures from ELSA and NHANES showed that the differences between the U.S.
and England and across SES groups within each country are not due to biases in
self-reported disease or screening rates, because biological markers of disease
(although they have not been calibrated against one another) exhibit exactly
the same patterns. Finally, the results showed that these differences are not
solely driven by the bottom of the SES distribution, and that for many diseases,
the top of the SES distribution (which in the U.S. has near universal health
insurance coverage) is less healthy in the United States as well.
Surprisingly, English lower SES individuals have better health than high SES
U.S. individuals. This is a provocative finding, that U.S. residents in late
middle-age are much less healthy than their English counterparts and that these
differences exist at all points of the SES distribution. Possible explanations
include survival advantages among U.S. adults with chronic illness, behavioral
differences in risk factors not (or imperfectly) measured in these studies,
psychosocial factors, the obesity epidemic (which is more advanced in the
U.S.), differences in health care systems, social policy contexts other than
medical care (e.g., social retirement benefits, unemployment compensation, sick
pay, housing policies, transportation options, social integration, etc.), how
health influences wealth (e.g., in the U.S., major health events lead to wealth
depletion), measurement differences across studies, quality and comparability
of biospecimen assays, etc.

A subsequent analysis using data from the HRS, ELSA, and the
Survey of Health, Ageing and Retirement in Europe (SHARE) found similar results
(Avendano, 2009). American adults ages 50-74 of all wealth levels reported
worse health than did European adults at comparable wealth levels. Indeed, on
many measures England was shown to have worse health than other European
countries. Similar to the paper discussed above, this analysis excluded U.S.
minorities, indicating that the worse health of Americans compared with
Europeans cannot be attributed to racial disparities within the United States.
And, similar to the U.S.-U.K. results, this analysis also found that the
disparities were only partially explained by differences in a standard set of
behavioral factors. Finally, while poor Americans were at particularly worse
health compared with their English or other European counterparts in this
analysis, even well-off Americans reported health comparable to substantially
poorer Europeans – suggesting that access to and quality of health care is unlikely
to be the full explanation.

Cross-national analyses provide insight into potential
causal explanations for observed differences in health and longevity because
institutional factors vary (e.g., universal health care in England at all ages
vs. universal health care after age 65 in the U.S.). However, comparative
analyses can also be done within the U.S. where there is also variation.
Extensive research has focused on health disparities within the U.S. and many
investigations have documented the consistent gap in measures of mortality and
functional health by race, income, social class, education, community
characteristics, insurance coverage, health care access and utilization,
quality of care, etc. Less has been done exploiting the internal variations by
geography in the U.S. Using data from the U.S. Bureau of the Census and the
National Center for Health Statistics, researchers have divided the U.S. into
eight subgroups based on a number of sociodemographic and geographical
variables (such as location of county of residence, race and income), which
they termed the “eight Americas” (Murray, 2006). They found disparities in
mortality across the “eight Americas” that are enormous by international
standards and that cannot be explained by race, income or basic health-care
access and utilization alone. A related analysis looked at trends in U.S.
county mortality and cross-county mortality disparities from 1961-1999,
including the contributions of specific diseases to county level mortality
trends (Ezzati, 2008). This study found that there was a steady increase in
mortality inequality across the U.S. counties between 1983 and 1999, resulting
from stagnation or increase in mortality among the worst-off segment of the
population, and that female mortality increased in a large number of counties,
primarily because of chronic diseases related to smoking, overweight and
obesity, and high blood pressure. Other examples of U.S. geographic
disparities in health include scholarship on the “stroke belt”. While no
consensus has been reached to explain geographic differences in stroke
mortality, recent research suggests that both early life exposures and adult
residence independently contribute to stroke mortality risk (Glymour, 2009).

A recent National Academy of Sciences panel determined,
based on available evidence, that past smoking rates are a major reason for
shorter lifespans in the U.S. compared to other high-income countries, and that
obesity rates in the U.S. also appear to be a significant factor. The summary
report from the National Research Council, which also identified research gaps,
is entitled "Explaining Divergent Levels of Longevity in High Income
Countries" (NRC, 2011) and is available at http://www.nap.edu/catalog.php?record_id=13089.
A volume of background scientific papers is entitled "International
Differences in Mortality at Older Ages: Dimensions and Sources" (NRC,
2011) and is available at http://www.nap.edu/catalog.php?record_id=12945.

Research Scope

Applications are encouraged that pursue possible
explanations for the divergent trends that have been observed in health and
longevity at older ages, both across industrialized/high life expectancy
nations and across the U.S. by geographic area. Research projects are not
restricted to using NIA-supported datasets and may propose research using any
relevant data. Applicants are encouraged to consult the aforementioned
National Research Council consensus report entitled “Explaining Divergent
Levels of Longevity in High Income Countries” and a companion volume of
scientific papers written or invited by the NRC consensus report committee,
entitled “International Differences in Mortality at Older Ages: Dimensions and
Sources” (see References below). These reports discuss potential explanations
for the observed divergent trends that have been observed in longevity and
health at older ages across high-income countries; discuss internal
heterogeneity in the U.S.; present the available cross-national harmonized data
useful for analysis; and raise many interesting and provocative hypotheses for
future research. Following a previous Funding Opportunity Announcement (RFA-AG-11-004),
the National Institute on Aging funded seven research projects exploring the
extent and determinants of international and U.S. regional differences in
health and longevity at older ages. These projects are described at this
website: http://www.nia.nih.gov/research/announcements/2012/12/updates-selected-rfas .

Applications submitted to this Funding Opportunity
Announcement should advance beyond the NAS reports and existing projects to assess
determinants of trends and of international and interregional differences,
quantify the contributions of particular determinants, point the way to likely
policy or systemic changes that can improve population health measurably in the
United States, and make existing studies more suitable for comparative analyses
of health status and longevity in middle aged adults. Projects appropriate for
this R03 mechanism include pilot or feasibility studies, secondary analysis of
existing data, small, self-contained research projects, calibration of measures
across studies, linkages to administrative data sources, and development of
research methodology. Examples of approaches and topics include but are not
limited to:

The prevalence of a condition is a function of its incidence,
duration, and survival. These three parts have not been adequately
differentiated in the comparative analysis of major chronic conditions. Do
Americans have a higher prevalence of major conditions because they have a
higher incidence of a condition, are more likely to have it diagnosed earlier
or at all, or experience better survival from it?

The cross-national studies discussed above found that differences
were not explained by behavioral risk factors. Applicants are encouraged to
conduct investigations of the adequacy and comparability of the behavioral risk
factors measured in these studies and consider whether a fuller set of risk
factors and would offer additional explanatory power. Also, these studies do
not include data on past differences in risk factors, or may not adequately
measure cumulative exposure over the life course. Behavioral risk factors of
interest include: physical activity, exercise, diet, eating patterns,
tobacco/smoking, alcohol, drug use and abuse, obesity, sleep duration, sleep
quality, time use, etc. Environmental exposures and risk factors are also of
interest. Studies that quantify the contribution of risk factors and conditions
to observed differences (as, for example, Preston and Stokes, 2011, did for
obesity) are encouraged.

Smoking behavior has been hypothesized to account for a
significant portion of the mortality differential among countries. Recent
methodological research estimating the number of deaths attributable to smoking
has shown that the ranking of the U.S. in international comparisons of
longevity is heavily affected by the smoking history of American men and women
(Preston, 2009). When the mortality profiles of a set of industrialized
countries were adjusted by removing the effect of smoking, the relative
position of both U.S. women and men significantly improved. Related analysis
suggests that because of reductions in smoking that have already occurred or
can be reliably projected, U.S. mortality is likely to decline much faster than
is commonly anticipated (Wang and Preston, 2009). Applicants are encouraged to
study the effect of smoking and cohort smoking histories as a potential
explanation for the U.S.’s international standing in health and longevity.

Psychosocial factors such as social support, social integration,
stress, well-being, etc. have not adequately been studied as potential
explanations for observed health and longevity differences. Applicants are
encouraged to develop better measures of psychosocial factors for incorporation
into the above-mentioned NIA-funded cross-national surveys of the older
population, and investigate their potential explanatory power.

Available cross-national comparative data do not include much
information on early life factors. Applicants are encouraged to gather
retrospective data (both recall data and information from administrative
records including vital statistics) from older cohorts in ongoing studies.

Social policy contexts differ between the U.S. and Europe and it
has been hypothesized that contextual factors may have causal effects in
producing the observed health disadvantages in the U.S. Studies of the effect
of contextual factors including retirement benefits, unemployment compensation,
sick pay, working conditions, housing policies, transportation options, social
integration etc. are encouraged.

Despite its huge policy implications, the role of health and
long-term care systems in international variations in disease prevalence and
mortality is only beginning to be understood. The cross-national, longitudinal
studies of older people referenced in this FOA, which have frequent follow-up
via biomarkers and linked data on medical records, should be further exploited
to shed light on differences in the way medical systems interface with
patients, and how such differences may have survival and disability
implications. Applicants are also encouraged to take advantage of available
natural experiments in medical care as they occur internationally.

Applicants are encouraged to calibrate the biomeasure assays
(e.g., assays of CRP, cholesterol, etc.) and self-reported physical performance
measures across datasets used for comparative analyses.

References:

Avendano, M., Glymour, M.M., Banks, J. and Mackenbach, J.P.
(2009) Health Disadvantage in U.S. Adults Aged 50 to 74 Years: A Comparison of
the Health of Rich and Poor Americans with that of Europeans. American Journal
of Public Health 99/3:540-47.

Banks, J., Marmot, M., Oldfield, Z. and Smith, J.P. (2006)
Disease and Disadvantage in the United States and England. Journal of the
American Medical Association 295:2037-45.

Banks J, Muriel A, Smith JP. (2010) Disease prevalence,
disease incidence, and mortality in the United States and in England.
Demography. 2010;47 Suppl:S211-31.

Ezzati, M., Friedman, A.B., Kulkarni, S.C., and Murray,
C.J.L. (2008) The Reversal of Fortunes: Trends in County Mortality and
Cross-County Mortality Disparities in the United States. PLoS Med 5(/4):
e66:557-68.

Glymour, M., Avendano, M., and Berkman, L.F. (2007) Is the
‘Stroke Belt’ worn from childhood? Risk of first stroke and state of residence
in childhood and adulthood. Stroke 38: 2415-21.

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide, with the following modification:

No publications or other printed material, with the exception of
pre-printed questionnaires or surveys, may be included in the Appendix.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects
that realistically can be completed in two years and that require limited
levels of funding. Because the research project usually is limited, an R03
grant application may not contain extensive detail or discussion. Accordingly,
reviewers should evaluate the conceptual framework and general approach to the
problem. Appropriate justification for the proposed work can be provided
through literature citations, data from other sources, or from
investigator-generated data. Preliminary data are not required, particularly in
applications proposing pilot or feasibility studies.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have complementary
and integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement, improvement,
or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not
involve one of the six categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to comments
from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.